PPT-IRB gripes? Show the data.

Jeffery W Rodamar Workshop on Revisions to the Common Rule In Relation to Behavioral and Social Sciences National Research Council March 2122 2013 1 Disclaimer This presentation is intended to promote the exchange of ideas among. Find us online. Information available online. IRB procedures and bylaws. IRB FAQs. Definition of research. Link to the CITI ethics training. Application form. Instructions to fill out the application form. Show the data.. Jeffery W. Rodamar. Workshop on Revisions to the Common Rule. In Relation to Behavioral and Social Sciences . National Research Council. March 21-22, 2013. . 1. Disclaimer . This presentation is intended to promote the exchange of ideas among researchers and policy makers. The views expressed in it are those of the author as part of ongoing research and analysis and do not necessarily reflect the position of the US Department of Education or any other Common Rule department or agency. . Agenda. GRU IRB Development and Changes. WIRB-Copernicus Group. Process for transfer of Chesapeake IRB protocols. Process for the new WIRB submissions. GRU IRB Development and Changes. WIRB and IRBNet. Micheal A. Kuhn, MD. Vice Chair, Loma Linda University. Institutional Review Board. What type of . research needs. IRB review?. Anything and everything . that involves human subjects. Navigating the IRB process. Susan Loess-Perez, MS, CIP, CCRC. Director of Research Compliance. Office of Research Services. Graduate Thesis and Dissertation Conference. February 6, 2016. Purpose of IRB. What Requires Review. Levels of Review. COMPLIANCE PROGRAM:. Repository Protocols . and FAQs. Compliance Deadline: August 31, 2011. Kathryn Schuff, MD, MCR Andrea Johnson, JD. IRB Co-Chair Regulatory Specialist, ORIO. Agenda. What’s a repository?. A How-To Guide. http://www.uthsc.edu/research/research_compliance/IRB. /. (901) 448-4824. irb@uthsc.edu. UTHSC Institutional Review . Board (IRB). Charged with protecting human research subjects. Ensures compliance with the federal regulations (DHHS, FDA, & HIPAA) with regards to research applications, consent forms and other research materials to be used; and with regards to the conduct of the research itself. May 19, 2017. Topics. Drivers for Centralized IRB Review. Regulatory changes . Trial Innovation Network. How JHM IRB will address the Single IRB requirements . Key Decisions. When JHM is serving as the IRB of Record. & Where. Kevin L. Nellis, MS, CIP. Executive Director, Human Research Protections and Quality Assurance. Objectives. 2. WHY. is IRB approval required? . WHEN. do activities require IRB approval?. Overview of Today’s presentation . How do I know if I am using VA Resources? . What are the VA training requirements? . What do I do if I am storing PHI at my UI office?. Record retention policy . Where do I start?. IRB Process Basic Overview. https://research.uga.edu/hso/resources. History:. H. uman Subjects Research Protection. 4. 1974. Congress established National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Amy Krenzer, CIP, IRB Coordinator. Hila Berger, MPH, CIP, Research compliance Officer. 1. Objectives . What is the Institutional Review Board (IRB) responsible for? And why?. What is Human subjects research?. Institutional Review Board. What is an IRB?. What is its job?. What are its guiding Principles?. Belmont Report (i.e., Respect for Persons, Beneficence, Justice). Code of Federal Regulations, Title 45 – Public Welfare, Part 46 Protection of Human Participants (aka . Let’s Play Jeopardy!. Go to the Bank. Time for Your Review. Fast Lane. I’ve Got Friends. 200. 200. 200. 200. 400. 400. 400. 400. 600. 600. 600. 600. Go to the Bank for 200. You have a population of interest (e.g., women who have been diagnosed with breast cancer) that you would like to contact for future studies..